Kornimate/medical-research-clean huggingface dataset:
study of recombinant human coagulation factor viia for injection (fⅶa) in patients with hemophilia.

Conditions: Hemophilia A With Inhibitor; Hemophilia B With Inhibitor

Summary: aim of this trial is to assess the pharmacokinetics and pharmacodynamics (pk/pd) of recombinant human coagulation factor viia for injection (fⅶa) in patients with hemophilia.


Eligibility criteria:
inclusion criteria: * diagnosed as congenital hemophilia a or b, and meet the following conditions: a. fⅷ\ 5 bu (nijmegen modified bethesda method of detection). * age ≥18 and ≤75 years, male or female. * no other drugs for the treatment of hemophilia have been used within 48 hours (2 days) before administration, including prothrombin complex and any fvii products, cryoprecipitate, fresh plasma and whole blood, etc. * no obvious bleeding symptoms during pk medication (no active bleeding). * subjects of childbearing age agree to take effective contraceptive measures throughout the trial period, and continue to 28 days after the last medication. * volunteer to participate in this study, sign an informed consent form, have good compliance, and be able to cooperate with the experimental observation. exclusion criteria: * any other bleeding disease except congenital hemophilia a or b. * patients with any previous medical history or symptoms of arterial or venous thromboembolic events (such as atherosclerosis, myocardial infarction, ischemic stroke, transient ischemic attack, deep vein thrombosis or pulmonary hypertension embolism) or disseminated intravascular coagulation (dic). * baseline and previous values of fⅶ inhibitor or rfviia inhibitor is positive. * vitamin k deficiency. * human immunodeficiency virus (hiv) positive and cluster of differentiation 4 (cd4) count ≤200/μl, the number of virus carriers ≥200 particles/μl or ≥400000 copies/ml. * subjects plan to perform elective surgery during the trial period. * those who are allergic to test drugs or any excipients. * severe anemia and need blood transfusion. * platelet count \<80×10\^9/l. * obvious liver or kidney damage: alt or ast\>2.5×uln, or total bilirubin\>1.5×uln or serum creatinine\>1.5×uln. * have a history of cardiac surgery and need anticoagulation therapy; severe heart disease, including myocardial infarction, cardiac insufficiency grade 3 or above, the current new york heart association cardiac function grade ii-iv. * hypertension that cannot be controlled with drug treatment: systolic blood pressure\> 150 mmhg or diastolic blood pressure\> 90 mmhg. * participated in other clinical studies (except fviia, fⅷ and fⅸ trials) within one month before the first medication. * diagnosed with hereditary diseases such as fructose intolerance, glucose malabsorption or sucrose-maltase deficiency. * alcoholism, drug abuse, mental disorders, other severe acute or chronic diseases, greater abnormal laboratory values, and those who are considered unsuitable by the researcher.
a comparison between orthodontic and non-orthodontic patients on oral indexes and salivary ph and quality

Conditions: Dental Plaque; Saliva Altered

Summary: this study aims to assess the caries susceptibility in pediatric patients aged 6-14 years old using saliva-check buffer salivary tests. a total of 40 patients will be enrolled, divided into two groups: 1. group a (pre-orthodontic treatment): this group will include pediatric patients who have completed dental treatments (mechanical debridement, fillings, extractions) and have not yet started orthodontic treatment. 2. group b (orthodontic treatment): this group will consist of pediatric patients who have been undergoing orthodontic treatment for at least 6 months.

this study aims to assess the caries susceptibility in pediatric patients aged 6-14 years old using saliva-check buffer salivary tests. a total of 40 patients will be enrolled, divided into two groups: 1. group a (pre-orthodontic treatment): this group will include pediatric patients who have completed dental treatments (mechanical debridement, fillings, extractions) and have not yet started orthodontic treatment. 2. group b (orthodontic treatment): this group will consist of pediatric patients who have been undergoing orthodontic treatment for at least 6 months. ethical considerations: the study will be conducted in accordance with the declaration of helsinki and the norms of the good clinical practice. patient enrollment: patients meeting the inclusion criteria will be identified from the dental clinic's patient records. parents or legal guardians will be approached to obtain informed consent for participation in the study. baseline assessment: baseline dental examinations will be conducted to assess the dental health status of each patient, recording the following indexes: dmft (decayed, missing, filled teeth), dmfs, pcr. then, saliva collection and testing will be performed with saliva-check buffer. data analysis: data will be statistically analysed. normality test will be performed, and a parametric or non-parametric test will be performed to compare the two groups for all the variables tested. significance threshold will be predefined for p\<0.05.

Eligibility criteria:
inclusion criteria: * patients about to begin orthodontic treatment or already undergoing orthodontic therapy * willingness to undergo saliva-check buffer salivary tests. * parental or legal guardian consent for participation in the study. exclusion criteria: * patients with systemic medical conditions that may affect the results of salivary tests. * patients unwilling or unable to cooperate for saliva sample collection required for the tests. * patients who have taken antibiotics or other medications that could influence saliva composition in the weeks prior to testing. * patients with oral anomalies that may interfere with data collection or affect test results.
transcutaneous electrical nerve stimulation on pain intensity of patients with hip arthroplasty

Conditions: Hip Fractures

Summary: fifty patients with hip arthroplasty were purposively recruited for the study. they were allocated into two groups randomly with equal number. one group had ten, other served as control. pain intensity was measured every day of the treatment.

subjects that participated were post-surgical patients with hip arthroplasty receiving treatment at orthopedic ward of obafemi awolowo university teaching hospitals complex (oauthc), ile-ife. excluded from the study were subjects who had surgery but have infected wound, those with deep vein thrombosis, and those with thrombophlebitis post-surgery. the subjects were allocated randomly into 2 groups; one group of 25 patients was on tens (experimental group) and the other group of 25 patients was on their normal drugs without tens (control group). before the start of intervention, the procedure of the intervention and the way the subject would feel during the course of the intervention was explained to the subject and the consent of the patient was obtained. the procedure was as follows:the visual analogue scale and oxford hip score was administered prior to the treatment to ascertain their pain level and hip disability before the treatment. the site of intervention (5cm away from incision site) was cleaned properly with cotton wool soaked in methylated spirit in an outward motion. before the self-adhesive, pre gelled electrodes was placed on the cleansed sites. the tens unit was switched on and the parameters was adjusted to the required. for this study, parameters used are: 100µs pulse duration, 100hz frequency and an intensity comfortable for the patient for a duration of 15 minutes. at the expiration of treatment, the electrodes were removed. the treatment was carried out twice a day for three days in addition to the normal analgesic and antibiotics drugs taken by the patient. after the last treatment session, vas and oxford hip score was re-administered to ascertain their pain intensity and hip disability level. for the group with no intervention the vas and oxford hip score was administered on the first day of contact to ascertain pain intensity and hip disability level . the subject continued on the normal analgesics only till the third day and vas and oxford hip score was re-administered to ascertain their pain intensity and hip disability level.

Eligibility criteria:
inclusion criteria: patients who recently had hip arthroplasty were recruited for this study exclusion criteria: * subjects who had surgery but have infected wounds. * patients who had deep vein thrombosis post-surgery. * patients who had thrombophlebitis post-surgery.

Keywords: tens, vas, oxford-hip-score, hip-arthroplasthy, pain-intensity
obstructive sleep apnea treatment and insulin sensitivity in pregnancy

Conditions: Obstructive Sleep Apnea; Pregnancy Related; Insulin Sensitivity

Summary: this study will evaluate the effect of treatment of obstructive sleep apnea on insulin sensitivity in pregnant women. women in their third trimester of pregnancy will be randomized to receive treatment or no treatment for one month.

obstructive sleep apnea (osa) worsens over pregnancy and is related to increased risk of gestational diabetes. despite the fact that sleep disturbances are common during pregnancy, osa remains under-diagnosed, and poorly understood particularly in pregnancies affected by obesity. at least 25 percent of pregnancies are now affected by obesity, a leading risk factor for osa, yet the effect of treatment of osa on patterns of metabolic function and specifically decreased insulin sensitivity in pregnant women with obesity is a neglected area with major therapeutic implications to improve maternal health. inflammation with osa may decrease insulin sensitivity. continuous positive airway pressure (cpap) is a known effective treatment for osa and has been shown to improve insulin sensitivity outside of pregnancy. our overall hypothesis is that, compared with standard care, cpap will improve nighttime breathing, blood and tissue oxygenation, decrease markers of inflammation, and increase insulin sensitivity. using a randomized controlled trial, we will determine the effect of cpap on metabolic dysfunction induced by osa in pregnant women with obesity.

Eligibility criteria:
inclusion criteria: * 28-32 weeks pregnant * age 20-39 * bmi 30-40 kg/m2 pre-pregnancy (or first trimester) * obstructive sleep apnea (ahi≥15) * have a singleton pregnancy exclusion criteria: * diabetes (gdm, type 1 or type 2) * using beta blockers or glucocorticoids * have children who are ≤2 yrs old (risk of disrupted sleep) * diagnosed sleep disorders (other than sleep apnea) * night work schedule * diagnosed congestive heart failure * diagnosed lung disease (e.g. asthma, chronic obstructive pulmonary disease) * pre-gestational hypertension
intra individual evaluation of uremic toxin levels in hemodialysed patients

Conditions: Chronic Kidney Disease

Summary: chronic kidney disease (ckd) is characterized by a irreversible decrease of kidney functions. it is characterized by accumulation of solutes called uremic toxins. uremic toxins levels are implicated in cardiovascular complications associated with ckd. several protein-bound toxins have been implicated in the increased cardiovascular risk such as indoxyl sulfate (is), p cresol sulfate (pcs) and more recently the indole acetic acid (iaa). all clinical studies are performed with a single measurement at baseline assuming that the toxin levels are stable over time. the variability of uremic toxins level is not known. furthermore, little is known concerning determinants of serum toxins level.

colonic absorption play a major role in is (indoxyl sulfate) and pcs level. is and pcs level are significantly reduced in patient with colectomy. to validate the measurement of uremic toxins level in serum as biomarkers for cardiovascular risk, we need to know about intra-individual variability over time and the impact of diet or digestive disorders on uremic toxin serum level. we propose a prospective study evaluating the intra-individual variability in 3 uremic toxins serum levels the si, the pcs and iaa. the main objective is to study the kinetics of three serum uremic toxins: the indoxyl sulfate, p cresyl sulfate and indole acetic acid (and thus determine the intra-individual variability) in a population of chronic hemodialysis patients during 1 year.

Eligibility criteria:
inclusion criteria: * major subjects of both sexes aged 18 and over * topics affiliates or beneficiaries of a social security scheme * haemodialysis patients whatever the etiology of renal failure for more than 3 months * patients not under antibiotic * agreeing to participate in the study and who signed a consent * patient able to understand a written questionnaire exclusion criteria: * pregnant or lactating women * detainees * adults under legal protection or unable to consent * patient's refusal to sign the informed consent for participation * possibility of recovery of renal function (eg scleroderma) * patients carrying a replicating viral infection (hcv, hiv). * taking antibiotics in the previous month by 1 sampling
duobrii treatment of acne keloidalis nuchae (akn)

Conditions: Acne Keloidalis Nuchae; AKN

Summary: acne keloidalis nuchae (akn) is one of the chronic forms of scarring folliculitis, affecting predominantly the occipital scalp, seen mostly in men of african descent. duobrii has the advantage of being the only high potency topical steroid-retinoid combination approved by the fda with dermatologic indication. researchers are proposing the off-labeled use of duobrii for the management of early-mild akn. the research team hypothesizes that subjects will experience significant clinical improvement in lesion counts. patients will be followed with visits scheduled at baseline, 4 weeks, 8 weeks, and 12 weeks. during these in-clinic visits, there will be surveys regarding the severity of akn symptoms, photographs, and clinical assessments.


Eligibility criteria:
inclusion criteria: * male or female subject at least 18 years of age * subject is able to provide written informed consent and comply with the requirements of this study protocol * subjects have akn class i or ii (less than 6.5 cm in width) * subjects who are women of childbearing potential (wocbp) must have a negative urine pregnancy test at screening and must be practicing an adequate and medically acceptable method of birth control for at least 30 days prior to day 0 and at least 6 months after the last dose of study. acceptable methods of birth control include: * intrauterine device (iud) oral; * transdermal; * implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); * tubal ligation; * abstinence; * barrier methods with spermicide. * if not of child-bearing potential, subjects must have: * a sterile or vasectomized partner; * have had a hysterectomy; * a bilateral oophorectomy or be clinically diagnosed infertile; * or be in a menopausal state for at least a year. * subject is judged to be in good general health as determined by the principal investigator. exclusion criteria: * unable to understand and provide written consent * have received prior intralesional steroids for akn within the past 6 months * are using topical steroids or topical medications on their scalp within 4 weeks * have used duobrii on the scalp for akn or other scalp disorders * subject is pregnant or breastfeeding * use of prior systemic medication for akn or acne (doxycycline or isotretinoin) or hair loss in the last 6 months * currently using topical minoxidil or prior use within the past 3 months * have a history of other or other active scalp/hair disease or other forms of or other forms of alopecia * are on systemic steroids or other immunosuppressants * have a history of auto-immune disease, thyroid disorder, or hypersensitivity to steroids.
soy peptide, conjugated linoleic acid, overweight or obese, body composition

Conditions: Overweight or Obesity

Summary: soybean peptides are a mixture of active peptides obtained from the hydrolysis of soybean protein, which have biological activities such as antioxidant, blood pressure lowering, anti-fatigue and lipid lowering, etc. they can regulate food intake, increase satiety, and reduce fat body ratio by reducing cholesterol and triglyceride content and stimulating cck secretion.conjugated linoleic acid (cla) is a set of linoleic acid with conjugated unsaturated double bond, the location and structure of the isomers have been approved by the ministry of health in china as a new resource food , widely used in areas such as health care products, functional foods and food additives, animal experiments showed that it has reduce tumor, atherosclerosis, obesity risk.therefore, in this study, the effect of conjugated linoleic acid combined with soybean peptide on overweight and obese people was investigated in a randomized controlled manner.

aim 1: to test the effects of combined supplementation of soybean peptide and conjugated linoleic acid on body fat, liver fat and muscle content of overweight and obese people;aim 2: to test the effects of combined supplementation of soybean peptide and conjugated linoleic acid on blood lipid, blood glucose, fat or inflammatory factors in overweight and obese people; aim 3: test the impact of the above interventions on safety indicators (safety indicators: liver and kidney function, self-reported adverse reactions or diseases). aim 4: to provide scientific basis for the development of functional food for weight loss and muscle gain.the public health significance of this research is that find a new functional food for weight loss and muscle gain.

Eligibility criteria:
inclusion criteria: * age - 18-65 years old; * gender-not limited; * bmi-24-35 kg/m2; * body fat rate-male ≥25%, female ≥30% (body fat meter can be used for screening, dxa is used for diagnosis); * waist circumference: male \>90cm, female\>80cm (not required). exclusion criteria: * suffer from serious diseases such as heart, liver, kidney, brain, hematopoietic, immune, thyroid, malignant tumors; * take drugs or supplements that have a known effect on body fat and muscle mass; * those whose weight has changed more than 10% in the past 3 months; * those who have cognitive or mental disorders and cannot conduct questionnaire surveys; * people who are physically disabled and cannot walk normally; * those whose compliance with the pre-experiment period cannot meet the requirements; * fail to sign the informed consent form, or other researchers think it is not suitable for participants

Keywords: soy peptide conjugated linoleic acid overweight or obesity body composition fatty liver disease rct
effect of intravitreally administered aiv007 in subjects with neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: to determine safety, pharmacokinetics, and duration of effect of intravitreally administered aiv007 gel suspension in subjects with neovascular age-related macular degeneration

aiv007 is a multiple kinase inhibitor of vascular endothelial growth factor receptors (vegfr 1, -2 \& -3); fibroblast growth factor receptors (fgfr-1, -2, -3 \& -4); and platelet-derived growth factor receptors (pdgfr-α \& β)1. lenvatinib is the active pharmaceutical ingredient in aiv007 formulation that is fda-approved for oral administration for patients with advanced renal cell carcinoma (rcc), differentiated thyroid cancer (dtc), unresectable hepatocellular carcinoma (hcc), and advanced endometrial carcinoma (lenvima uspi 2021; nda 206947). aiv007 is a novel, thermoresponsive gel suspension for intravitreal administration proposed to form a durable depot inside the eye. this monotherapy is being evaluated for the treatment of retinal and choroidal vascular disease. a single intravitreal treatment in 3 subjects was evaluated using 2 doses to evaluate depot formation, safety and biological activity by measuring visual acuity, reduction in retinal fluids associated with vision and effects of fibrosis.

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥ 50 years 2. subjects must provide written informed consent before any study-related procedures are performed 3. active subfoveal cnv in the study eye secondary to amd that has previously been treated with at least 3 intravitreal injections of an anti-vegf agent 4. bcva in the study eye 1. sentinel subjects only: 65 etdrs letters (20/50 snellen equivalent) or worse 2. all other subjects: 78 to 35 etdrs letters (20/32 to 20/200 snellen equivalent) 5. clear ocular media and adequate pupil dilation in both eyes to permit good quality photographic imaging exclusion criteria: 1. previous treatment for namd in the study eye, other than standard-of-care anti- vegf ivt injection, eg, cell therapy, brachytherapy, gene therapy 2. treatment with anti-vegf in the non-study eye 2 weeks prior to baseline 3. presence of diabetic retinopathy or glaucoma in either eye 4. spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (prior to cataract or refractive surgery) 5. presence of active infection or inflammation within 30 days prior to screening 6. presence of contraindications to anti-vegf treatment, including myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke within the last 3 months of baseline 7. uncontrolled hypertension or diabetes mellitus

Keywords: neovascular age-related macular degeneration
vale+ tu salud: corner-based randomized trial to test a latino day laborer program adapted to prevent covid-19

Conditions: COVID-19

Summary: the purpose of this study is to adapt and pilot test the feasibility of implementing a corner-based risk reduction program that aims to assist latino day laborers (ldl) in their efforts to adhere to covid-19 mitigation practices, including receiving the covid-19 vaccine, using personal protective equipment (ppe), and practicing social distancing.


Eligibility criteria:
inclusion criteria: * self-identify as hispanic or latino * be present at the corner for the purposes of looking for work exclusion criteria: * have not been previously hired to work at a corner * symptoms of covid-19 in the previous 48 hours

Keywords: latino day laborers
a comparison of three methods of hemoglobin monitoring in pediatric patients undergoing major surgery

Conditions: Child

Summary: investigators compare the accuracy of the sphb and hemocue with blood hb levels

the goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. during general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and sphb

Eligibility criteria:
inclusion criteria: paediatric patients scheduled for major orthopaedi or neurosurgical process under general anesthesia arterial catheter necessary in the anesthetic protocol. bmi\<30 no opposition holders of parental authority and children. exclusion criteria: hemoglobin disease pretreatment with erytropoietin or iron

Keywords: major pediatric surgery hemoglobin measurement